Summary of Field Safety Notices - June 2020

Notice type: 3rd Party Publications

Date: 02/07/2020

 

Further Information:
Summary of Field Safety Notices - June 2020

Abbott
Alinity ci-series System Control Module - FSN A
Advice regarding a software upgrade. HPRA Ref: V44192

Alinity ci-series System Control Module - FSN B
Advice regarding a software upgrade. HPRA Ref: V44192

Bard Access Systems, Inc
BARD SafeStep™ Huber Needle Sets
Advice regarding a device removal. HPRA Ref: V44216

Biosense Webster Ltd.
CARTO® 3 System Version V7.1.80, CARTO VISITAG® Module
Advice regarding a software upgrade. HPRA Ref: V44206

Dexcom
Dexcom G4 PLATINUM and Dexcom G5 Mobile Receiver
Advice regarding the use of the device. HPRA Ref: V43958

Ethicon LLC
8-0 Blue Twisted Silk Suture
Advice regarding a device removal. HPRA Ref: V44501

Fannin LIP Galway
MUELLER HINTON AGAR + 5% BLOOD & NAD (4mm)(EUCAST)
Advice regarding a device removal. HPRA Ref: V43734

Galil Medical Ltd
IceFORCE & IcePearl 2.1 CX Cryoablation Needles
Advice regarding a device removal. HPRA Ref: V44018

GE Healthcare
CARESCAPE Patient Data Module (PDM)
Advice regarding a software upgrade. HPRA Ref: V43990

Medtronic Inc.
CareLink Programmer; CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V37585

CareLink SmartSync™ Device Managers
Advice regarding a software upgrade. HPRA Ref: V44020

Medtronic Xomed, Inc.
Console IPC-ENT, Microdebrider M5 multi-purpose surigcal power tool system
Advice regarding a device removal. HPRA Ref: V44130

Prodimed
Sterile Single Use Prodimed Medical Devices
Advice regarding a device removal. HPRA Ref: V43953

ResMed
Stellar 100/ Stellar 150
Advice regarding a software upgrade. HPRA Ref: V44074

Roche Diagnostics GmbH
Elecsys Anti-CCP - FSN Updated
Advice regarding the use of the device. HPRA Ref: V40624

Roche Molecular Systems
MagNA Pure 96 System
Advice regarding a software upgrade. HPRA Ref: V44025

Siemens Healthcare Diagnostics Inc
Chemistry Calibrator - FSN 1
Advice regarding the use of the device. HPRA Ref: V44001

Chemistry Calibrator - FSN Updated
Advice regarding the use of the device. HPRA Ref: V44001

Smith & Nephew Inc., USA
SUTUREFIX ULTRA 1.7mm Drill (S)
Advice regarding a device removal. HPRA Ref: V44227

Stryker Medical
LIFEPAK® 500 AED - FSN
Advice regarding the use of the device. HPRA Ref: V44148

LIFEPAK® 500 AED - DiscontinuationLetter
Advice regarding the use of the device. HPRA Ref: V44148

Teleflex Medical
Arrow® FlexTip Plus(R) Epidural Kit with NRFit(R) connector
Advice regarding a device removal. HPRA Ref: V43959

Various Manufacturers
Paclitaxel-coated Balloons and Paclitaxel-Eluting Stents
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38414


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